Recall notice · FDA Recall Press Releases

StuffbyNainax LLC: FDA Recall Notice (Dec 16, 2025)

Agency action: Dec 16, 2025Record ID: fda_recall_p-fcd056453c7d0682
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What happened

Original notice title

StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared Sildenafil and Tadalafil

From the archived source record

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. More Recalls, Market Withdrawals, & Safety Alerts Recalls, Market Withdrawals, & Safety Alerts Recall Resources Enforcement Reports Industry Guidance For Recalls Major Product Recalls Huntsville, Texas, StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are active ingredients in FDA-approved prescription drugs used to treat male erectile dysfunction and belong to a class of drugs known as phosphodiesterase type‑5 (PDE‑5) inhibitors. Products containing sildenafil or tadalafil cannot be marketed as dietary supplements. MR.7 SUPER 700000 capsules are considered an unapproved new drug for which safety and efficacy have not been established and are therefore subject to recall. Consumption of products containing undeclared sildenafil or tadalafil may cause serious health risks. These ingredients may interact with nitrates found in certain prescription medications (such as nitroglycerin) and may result in a dangerous drop in blood pressure, which can be life‑threatening. Individuals with diabetes, high blood pressure, high cholesterol, or heart disease frequently take nitrates. Adult males who use nitrates for cardiac conditions are at the greatest risk. The tainted MR.7 SUPER 700000 capsules are marketed as a dietary supplement for male enhancement. The affected product does not have lot numbers or expiration dates. The product was distributed nationwide in the United States to a limited number of online customers between August 2025 and November 2025.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
Published recall notice
Source checked
Jul 16, 2026
Record revision
e3f805b6877e

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
Dietary supplement for male enhancement; November 2025
Company
StuffbyNainax LLC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.